Lewis 1999.
Methods | A single‐centre unmasked randomised controlled trial conducted during a 36‐month period. | |
Participants | 135 women with a diagnosis of PPROM ≤ 34 + 0 weeks' gestation at Louisiana State University School of Medicine, Shreveport, Louisiana, USA, and who were stable after 24 hours' monitoring. 66 (66 available for analysis) women were randomised to the biophysical profile group and 69 (69 available for analysis) women were randomised to the nonstress test group. | |
Interventions | Daily nonstress test versus daily modified biophysical profile. | |
Outcomes |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation | Low risk | Random number tables with a 1:1 match were used to generate allocation sequences. |
Allocation concealment | Low risk | Allocation cards were kept in opaque envelopes and not opened until after informed consent was obtained. |
Blinding (participants and personnel) | High risk | The nature of the intervention prohibited participant or clinician blinding. |
Blinding (outcome assessment) | Unclear risk | Outcome assessor blinding is not described, therefore the risk of bias arising from this is unclear. |
Incomplete outcome data addressed All outcomes | Low risk | No loss of participants to follow‐up at each data collection point. No exclusion of participants after randomisation. |
Free of selective reporting | Low risk | There is no suggestion of selective reporting of outcomes. All main outcomes described in the methods are reported in the results. |
Free of other bias | Unclear risk | The number of women with multiple gestations is not reported. These women were not excluded from the study, but a subgroup analysis of their effect has not been described. Therefore the risk of bias arising from the inclusion of women with multiple gestations in the analyses is unclear. |
PPROM: preterm prelabour rupture of membranes